Z-1137-2022 Class II Terminated
FDA device recall Z-1137-2022 was initiated by ProgenaCare on April 18, 2022 and is designated Class II. Reason for recall: Inner pouch seal may be inadequate resulting in lack of sterility. The recall status is terminated (terminated April 14, 2023). Affected quantity: 547 packages.
Recall Details
- Product Type
- Devices
- Report Date
- June 1, 2022
- Initiation Date
- April 18, 2022
- Termination Date
- April 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 547 packages
Product Description
progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.
Reason for Recall
Inner pouch seal may be inadequate resulting in lack of sterility.
Distribution Pattern
US Nationwide distribution in the states of AL, GA, FL, TN, and TX. There was no foreign/military/government distribution.
Code Information
(1) Model PM2012, lot #02SEP21-001, exp. 4/9/2024; lot #29SEP21-001, exp. 4/9/2024. (2) Model PM3002, lot #28OCT21-001, exp. 3/7/2024. (3) Model PM3004, lot #02DEC21-001, exp. 10/1/2023; lot #02SEP21-002, exp. 10/1/2023; lot #14OCT21-001, exp. 10/1/2023; and 23NOV21-001, exp. 10/1/2023. (4) Model PM3006, lot #02SEP21-003, exp. 10/1/2023; lot #03DEC21-001, exp. 10/1/2023; lot #14OCT21-002, exp. 10/1/2023; and lot #23NOV21-002, exp. 10/1/2023. (5) Model PM3010, lot #13JUL21-001, exp. 10/1/2023; and lot #15JUL21-002, exp. 3/6/2024.